Manuf Internship Exit Report
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Transcript of Manuf Internship Exit Report
Manufacturing Internship at Lloyd Laboratories, Inc.
Gilberto DianoVincent Rebultan
Kristina Gayle RodriguezJune 18, 2011
Company ProfileVision-Mission and Core Values
COM
PAN
Y PR
OFI
LE• Founded in Marikina in 1989• Corporate turnover of $10,000,000• Manufacturing facilities in Bulacan and Quezon
City in the Philippines and in India (Lloyd Laboratories, Private Limited)
• Major player in the pharmaceutical industry in the Philippines and in India
VISI
ON
• To support our marketing partners with the latest innovations in Pharmaceutical technology
• To become a global leader as a manufacturer of health care products by providing solutions and alternatives,
• To uplift the health and well-being of people.
MIS
SIO
N• To utilize the latest technology and provide
significant added value to our partner• To build a diverse, productive and challenging
workplace• To achieve market leadership in all segments of
our product line
CORE
VAL
UES
• We live, breath and exist in pursuit of products and services aimed at improving life.
• We exemplify honesty and integrity in all our actions.
• We are committed in taking care of our people and in giving them the opportunity to grow, to develop and to continuously exceed themselves.
• We accept and take on our social responsibility to the community we belong to.
• We believe in the higher purpose of things, to the greater responsibility of our existence and to the real reason for our being.
Quality Policy and ISO CertificationProducts and Services
QU
ALIT
Y PO
LICY
Strict adherence to USFDA, WHO, ISO and other statutory cGMP guidelines such as :• TGA-Australia (Therapeutics Goods
Administration)• UK-MHRA (United Kingdom Medicines &
Healthcare Products Regulatory Agencies)• MCC-South Africa (Medicines Control Council)• ANVISA-Brazil (National Health Surveillance
Agency)• INVIMA-Colombia (National Institute for the
Supervision of Foods and Medications)
QU
ALIT
Y PO
LICY
• Providing quality products and services that meet National and International Standards
• Routine training, effective communication and team building
• Continual upgrading of technical and quality systems
ISO Certification 9001:2000December 17, 1998The ISO 9001:2000 standard provides a
tried and tested framework for taking a systematic approach to managing the organization’s processes so that they consistently turn out product that satisfies customers’ expectationsIS
O C
ERTI
FICA
TIO
N
Toll ManufacturerPharmaceutical
Anti-infectives (e.g. Co-Amoxiclav, Anti-TB drugs), Analgesic, Anti-HPN, Antacid, Antidiabetic
CosmeticsPerfumes (e.g. Tupperware®, ), Detergent Powder, Lubricant (Bliss®), Facial cream (Placenta®)
HerbalTablets, capsules, Tea (e.g. Liveraide®, Taheebo®, Jimms® )PR
OD
UCT
S &
SER
VICE
S
Contract PackagingSecondary/Re-packaging of drugs manufactured by other companies and imported from other countries • Silver Sulfadiazine (Flammazine) Solvay
Pharma • Glucophage XR (Metformin) Merck
PRO
DU
CTS
& S
ERVI
CES
Organizational StructurePlant Layout and FacilitiesEquipment
PresidentVice PresidentChairmanPlant ManagerAVP
Manuf I, Manuf IICosmeticsQAQCMaterials ManagementO
RGAN
IZAT
ION
AL S
TRU
CTU
RE
ORGANIZATIONAL STRUCTURE
ORGANIZATIONAL STRUCTURE
PLANT LAYOUT
Penicillin
Cefalexin
Warehouse 1
(1) Dispensing(2) QA
Cool Room
(1) Solids(2) Liquids & QC(3) Cosmetics
Warehouse (CSI)
Warehouse 2
Gym
(1) Canteen(2) Offices
GR2 Clinic & Offices GR1
GH
Cold Storage A4 Blister Making
FACI
LITI
ESManufacturing ICompounding and packaging area for non-penicillin pharmaceutical products
SolidsUncoated & coated tablets, capsules, pellets
LiquidsSyrups, solutions, suspensions
Class 100,000 Area
FACI
LITI
ESManufacturing IICompounding and packaging area for penicillins & cephalosphorins
SolidsUncoated & coated tablets, capsules, pellets
LiquidsSyrups, solutions, suspensions
Class 100,000 Area
FACI
LITI
ESCosmetics Specialist, Inc. Production and packaging of cosmetics & household products
FACI
LITI
ESMaterials ManagementWarehouse; Storage for raw materials, bulk products, packaging materials and finished goods
Dispensing SectionBatching of raw materials for productionClass 1000
Quality Assurance OfficeSampling of raw materialsInspection of BP, PM & FG
FACI
LITI
ESQuality ControlAnalysis of raw materials, bulk products and finished goods (both pharma and cosmetic products)
EQU
IPM
ENT
Production
Fluid Bed DryerGels Cream MixerMixing Tanks*Labeling MachineCartoning MachineInkjet PrinterBlistering MachineStrip Packing MachineVolumetric Filling MachineRibbon MixerSachet Filling
EQU
IPM
ENT
Quality Control/Quality AssuranceDigital Caliper and Stokes-Monsato Hardness TesterAtomic Absorption SpectrophotometerFourier Transform Infrared & Near Infrared*Karl Fischer Titration ApparatusGas-Liquid ChromatographyMoisture DeterminationHPLCpH MeterDissolution ApparatusDisintegration ApparatusUV SpectrophotometerPolarimeterAutomated Micrometer
Knowledge and Skills AcquiredInsights
• Inquisitiveness• Increased sociability• Independence• Respect for and camaraderie with all,
regardless of position• Solidarity• Flexibility and hand dexterity• Cost-consciousness and speed
KNO
WLE
DG
E &
SKI
LLS
ACQ
UIR
ED
• Fortunate to be given the chance to evaluate the various departments – Opportunity to voice out concerns directly to supervisors in exit report
• The value of work – Learned about the hardships of Lloyd employeesIN
SIG
HTS
Problems Encountered(Aside from the fact that there were so many pretty
female interns and there’s only one Bert)
These are excerpts from our Exit Report on the cGMP Evaluation of the Various Departments of Lloyd.
Personnel
Professionalism, particularly with regards to the mode of interpersonal communication, must be observed at all times.
Inconsistent use of hard hats and safety shoes (Warehouse)
Some personnel are not properly clad with required lab attire and safety equipment (e.g. gloves). (Solids)
Premises
Bench in the gowning room is not utilized
properly Inadequate space in Liquids Department
specifically in Cartoning Line 1 Some employees are not properly clad with
their required laboratory gown especially in the compounding area. (Pen)
Inadequacy of working space hindering orderly and logical placement of equipment and materials to suit the operation and efficient flow of work. (Pen)
Premises
Materials are not properly stored in
orderly manner due primarily to inadequate space. They are stored off the floor and not sufficiently spaced. (Warehouse)
Materials are not stored under suitable environmental conditions.
There is insufficient ventilation and conditions are not monitored. (Cosmetics)
Inadequate practice of hand washing before and after entering the area and absence of (visual) reminders regarding this practice
Incomplete protective clothing (e.g. gloves for personnel involving in strip packaging and face masks for the stripping operator).
Smoking, drinking, keeping food, and use of perfume
Sanitation and Hygiene
The manual transfer of bulk material from its container to the machine is performed without gloves (CSI)
Unassigned operator that manipulate the machine with dirty hands (CSI)
Sanitation and Hygiene
Work Process
Lack of conscientiousness towards the work
process Operating with an open wound Dirty packaging materials returned at the assembly
line without decontaminating measures (e.g. measuring cup)
Rough handling of packaging materials (e.g. amber bottles)
Infrequent use of washing bottle when titrating (QC)
Illogical procedure in performing dissolution & UV spec testing (QC)
Malfunctioning of sealing machine was not addressed immediately resulting in incomplete or burned seals. (Pen)
Usage of plastic measuring apparatus (QC)
Some machines are rusty Filling machine frequently
malfunctions, causing several delays in production in a single run
Equipment
Recommendation
To allot less time in packaging and more time in Quality Control and to explore
other departments (e.g. PPIC, Arts/Documentation)
END